Kornimate/medical-research-clean huggingface dataset:
genotype-driven treatment of advanced non-small cell lung cancer based on mrna expression of ercc1 & rrm1 as first-line chemotherapy

Conditions: Non-small Cell Lung Carcinoma

Summary: this is a prospective phase ii trial, in patients with unresectable or metastatic nsclc using chemotherapy regimens which will be defined according to the mrna expression of ercc1 and rrm1 of the tumor cells.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (nsclc) (stage iiib or iv) 2. chemotherapy naïve patient (previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.) 3. age \> 18 4. performance status 0 to 2 by eastern cooperative oncology group (ecog) criteria 5. at least one measurable lesion by response evaluation criteria in solid tumors (recist) 6. adequate organ functions (assessed within 14 days of starting treatment) 1) bone marrow: absolute neutrophil count ≥ 1,500/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 9.0 mg/dl 2) liver: total bilirubin ≤ 1.5 x uln; aspartic transaminase (ast) and alanine transaminase (alt), alkaline phosphatase(alp) ≤ 2.5 x uln 3) kidney: serum creatinine ≤ 1.5 x uln 7. signed informed consent document exclusion criteria: 1. clinically significant serious illness or medical condition (infection) 2. prior systemic chemotherapy or immunotherapy for advanced nsclc. 3. presence of uncontrolled brain or leptomeningeal metastases 4. prior radiotherapy within 3 weeks of starting treatment 5. peripheral neuropathy equal to or greater than grade 2 by common terminology criteria for adverse events (ctcae) v4.0 6. pregnant or lactating 7. absolute contraindication of corticosteroid use 8. patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine

Keywords: on-small cell lung carcinoma chemotherapy naive patient
dexamethasone vs. dexmedetomidine for espb in pain management after spine surgery

Conditions: Spinal Fusion; Spine Disease; Spinal Stenosis; Erector Spinae Plane Block

Summary: effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.

this study is proposed to explore the effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery. after spine surgery, patients need good analgesia. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. the safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. an effective adjuvant, such as dexamethasone or dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect. there is considerable research where intravenous and perineural dexamethasone and dexmedetomidine use have been compared in adults. however, there is a massive lack of research regarding spine surgery and the erector spinae plane block. in this study, investigators compare perineural dexamethasone and dexmedetomidine. the investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: * patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region, * aged \>18 years and \<100 years * asa physical status 1, 2 or 3. exclusion criteria: * refuse to participate, * history of opioid abuse, * infection of the puncture site, * aged \ 100 years * asa 4 and 5
laser therapy effect as preventive measure for oral mucositis in children with hematological malignancies

Conditions: Oral Mucositis

Summary: introduction: among the most drastic complications of chemotherapy is oral mucositis(om). it is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(lllt) is gaining popularity. the use of lllt as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. also, the parameters used have not been optimized and no standard method has yet been established. based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced om. aim: to assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with hematological cancers. methods: this study is a randomized, prospective, double-blinded trial that will include acute myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. these patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. patient will be followed to asses the development of oral mucositis on prespecified time points.

this study is a randomized, prospective, double-blinded trial ( patient \& outcome assessor) that will include acute myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. these patients will be randomized by the clinical epidemiology unit using a computer-based method into two groups. group i: will receive low level laser therapy by diode laser (sirrolaser blue ™, usa) at 44 different points in the oral cavity for 5 consequent days from day 1 to day 5 of chemotherapy cycle along with the standard preventive protocol in the hospital. group ii: will receive a mock treatment which is the exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital. all patients will be assessed for oral mucositis grade using nci-ctcae scale v4 and who score on days 1,5,12,19 and 30 .

Eligibility criteria:
inclusion criteria: * pediatric patients diagnosed with acute myeloid leukemia. * children with a minimum age of 3 years and a maximum 18 years. * children with sufficient cooperation to accept the treatment and evaluation periods exclusion criteria: * patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation. * patients with dysplastic oral lesions.

Keywords: low level laser therapy oral mucositis
domiciliary management of dental erosion in patients with gerd with biomimetic hydroxyapatite

Conditions: Gastro Esophageal Reflux; Dental Erosion

Summary: the aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (gerd). patients consenting to participate to the study will undergo periodontal evaluation at the baseline. then, professional dental hygiene will be performed. patients will be randomly assigned to: * trial group: home oral hygiene with biorepair total protection + biorepair shock treatment twice a day * control group: home oral hygiene with biorepair total protection patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.

the aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (gerd). patients consenting to participate to the study will undergo periodontal evaluation at the baseline. then, professional dental hygiene will be performed. patients will be randomly assigned to: * trial group: home oral hygiene with biorepair total protection + biorepair shock treatment twice a day * control group: home oral hygiene with biorepair total protection patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.

Eligibility criteria:
inclusion criteria: * patients with dental erosion * no proton pumps before ph examination exclusion criteria: * no dental erosion * neurological and psychiatric diseases; * pregnant and/or breastfeeding women; * patients with poor compliance.

Keywords: biomimetic hydroxyapatite remineralization
carbetocin at elective cesarean delivery part 2

Conditions: Postpartum Hemorrhage

Summary: post-partum hemorrhage (pph) is a major cause of maternal death worldwide. oxytocin is the most common uterotonic drug used to prevent and treat pph in north america, however, there are some limitations to its use. oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. the society of obstetricians and gynecologists of canada (sogc) has recently recommended a single 100mcg dose of carbetocin at elective cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (pph), in lieu of the more traditional oxytocin regimens. carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. however, a dose response to determine the minimum effective dose of carbetocin has not yet been published. the investigators hypothesize that the minimum effective dose (ed90) is above 20mcgs and below 80mcgs in women undergoing elective cesarean delivery.

the society of obstetricians and gynecologists of canada (sogc) recently recommended a 100mcg intravenous bolus dose of carbetocin following cesarean delivery. studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. in addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. a dose response study conducted by cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. additionally, hypotension was noted for all dose groups studied. the results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. it may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Eligibility criteria:
inclusion criteria: * all patients planned for elective cesarean delivery under spinal anesthesia. * all patients who give written informed consent to participate in this study. exclusion criteria: * all patients who refuse to give written informed consent. * all patients who claim allergy or hypersensitivity to carbetocin or oxytocin. * all patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. * all patients with hepatic, renal, and vascular disease, * all patients requiring general anesthesia prior to the administration of the study drug.

Keywords: pregnancy postpartum hemorrhage cesarean delivery carbetocin
a study of symptoms and quality of life in patients with implantable cardiac defibrillators (icds) and their caregivers

Conditions: Quality of Life; Implantable Cardiac Defibrillators; ICDs

Summary: the purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (icds).


Eligibility criteria:
inclusion criteria: patients: * patient has an icd * age \> 18 * fluent in english * consistent and reliable access to a phone. caregivers of patients: * age \> 18 * fluent in english * consistent and reliable access to a phone exclusion criteria: * not having an icd

Keywords: quality of life implantable cardiac defibrillators icds
screening protocol for the evaluation of research participants

Conditions: Substance Abuse; Disorders

Summary: background: - the national institute on drug abuse (nida) uses a standardized set of procedures to develop a pool of potential participants for research studies. because some of the data collected during screening are used later for research, the screening itself is considered a study. an applicant to any nida study is considered a participant in nida screening. objectives: - to identify, recruit, and screen participants for nida research protocols. eligibility: - individuals 18 years of age and older who are able to provide informed consent. design: * individuals who are eligible for screening will undergo two interviews: a telephone interview and an in-person interview. the phone interview will determine eligibility for the in-person interview. * the in-person interview may require up to five visits to nida. the in-person visit will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff. * during screening, a photograph will be taken for confirmation of identity during subsequent visits for other studies. * no clinical care will be provided as part of screening.

through its clinical research protocols, the nida irp attempts to: elucidate the nature of drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse on the development, maturation, function, and structure of the brain and other organ systems. in support of the irp's work, the scientific goal of this screening protocol is to assess potential research participants' eligibility for nida irp research studies. screening will include medical and psychological tests and procedures. the data collected during screening are a unique and valuable source of information that aids in nida's mission. therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting nida about research participation and to analyze data so obtained, such as that on the prevalence and consequences of hiv/aids, viral hepatitis, and related diseases.

Eligibility criteria:
* inclusion criteria: 1. adults (at least age 18) 2. ability to understand and answer the questions as posed. exclusion criteria: 1. inability to provide valid informed consent.

Keywords: recruitment adult telephone selection testing
an observational study in clinical practice management of patients with biological drugs in monotherapy

Conditions: Rheumatoid Arthritis

Summary: this observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (dmards) or other biological drugs * patients treated with biologic dmards alone for at least 6 months exclusion criteria: * patients not willing or unable to give written informed consent for participation in this study * patients who are participating in any clinical trial at the time of this study
evaluation of relapse presence in multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis Relapse

Summary: purpose: this study aims to investigate the demonstrability of increased inflammation and neurodegeneration in multiple sclerosis (ms) patients in relapse period compared to ms patients in remission by cross-sectional analysis of in-vivo corneal confocal microscopy (ivcm), and to evaluate the alternations with a second ivcm administered at least 6 months after the relapse period. methods: this prospective, non-randomized-controlled, cross-sectional study included 58 ms patients which were grouped regarding the presence of relapse (ms-relapse group \[n=27\] and ms-control group \[n=31\]), and age-sex matched 30 healthy controls (hc). the corneal nerve fiber density (cnfd), the corneal nerve branch density (cnbd), the corneal nerve fiber length (cnfl), and dendritic cell (dc) density were evaluated in all ms patients and hcs by ivcm. if the patients in the ms-relapse group did not have an attack within 6 months, the same parameters were evaluated with the second ivcm. the patients with a history of optic neuritis or trigeminal symptoms were excluded.


Eligibility criteria:
inclusion criteria: * patients for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse * patients who were followed up with the diagnosis of rrms * healthy controls exclusion criteria: * being younger than 18 years old * having any other neurological or metabolic diseases * ophthalmological diseases * a history of optic neuritis and trigeminal symptoms * ocular trauma or surgery * contact lens use * the patients who had a relapse attack 6 months prior to the study

Keywords: multiple sclerosis, in-vivo corneal confocal microscopy, relapse, inflammation, neurodegeneration, neuroregeneration
the effect of multiple occupational therapies on functional remission and subjective recovery for schizophrenia

Conditions: Occupational Therapy; Schizophrenia; Remission; Well-Being, Psychological

Summary: objective: this study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. the intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services.

background: occupational therapies are one of the psycho-social intervention methods used in the treatment of serious mental disorders characterized by disability, such as schizophrenia. objective: this study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. the intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services. data were collected using the subjective recovery assessment scale and the functional remission of general schizophrenia scale.

Eligibility criteria:
inclusion criteria: * being in the 18-65 age group * have been diagnosed with schizophrenia for at least one year * be in remission of the disease * volunteering to participate in research * not have any physical health problems that would prevent their participation in the research exclusion criteria: * have a physical health problem that prevents participation in the research * having a communication problem * not willing to participate in research

Keywords: shizophrenic disorder occupational therapy remission well-being, psychological
translation of modified fatigue impact scale in urdu language

Conditions: Traumatic Brain Injury

Summary: cross cultural analytical study to translate modified fatigue impact scale mfis) in urdu language. along with the translated version by evaluating its validity and reliability among the patients of traumatic brain injury. no such study has been previously conducted in pakistan which translate this scale in urdu and follows the proper cross- culture adaptation.condition or disease: traumatic brain injury. convenient sampling technique would be used.

the mfis is a modified version of 40-item fatigue impact scale (fis). the mfis impact scale consist of 3 subdivisions containing 9 physical items , 10 cognitive items and 2 psychosocial. the maximum score is 84 which is obtained by the sum of all the questions the higher score means high impact on quality of life. this version should be answered by the patients with traumatic brain injury. it is the patient's self- report. as the mfis is well- developed measurement scale, it is meaningful to translate and validate this scale in urdu version. it is useful the study the effect of fatigue in the patients with tbi by using same measurement items so that a more direct comparison can be made. therefore, the aim of the study is to translate and validate the modified fatigue impact scale in urdu language the translation and cultural adaptation process would start after obtaining approval from the developer of the original mfis. this would be done according to who guidelines. translation will be done by symmetrical category. the purpose will be to gain uniformity in the translation of tool in both the target language and source language. this will involve 5 steps. (forward translation, synthesis 2, backward translation, synthesis 2 and pilot testing). phase 2 would be done according to the guidelines of cosmin in which psychometric properties will be measured.(reliability, internal consistency, construct validity and factor analysis.)

Eligibility criteria:
inclusion criteria * age 18-65 years * both male and female * patient able to read urdu language * any period of loss of consciousness after 1 hour of injury * patients who can actively participate in community * for comprehension patients with the mmse score \> 25 will be included exclusion criteria: * patients able to perform 5 meter walk test * patients having score \>6 in fim scale * for alcohol abuse patients with the score \< 8 in audit scale * any other neurological disease including alzheimer, parkinson's disease and schizophrenia

Keywords: fatigue, tbi
effect of erig injection on day 7 after first dose of rabies vaccination to rabies immune response

Conditions: Rabies

Summary: no study was conducted to evaluate the rabies neutralizing antibody titers after rig injection on day 7. the only study that has supported the delay of rig administration was done in 1996 by our institute, of which rig was given on day 5 with the original thai red cross intradermal regimen (2-2-2-0-1-1).

rabies immunoglobulin (rig) should be administered as soon as possible after the initiation of post-exposure prophylaxis. rig should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after rig injection on day 7. the only study that has supported the delay of rig administration was done in 1996 by our institute, of which rig was given on day 5 with the original thai red cross intradermal regimen (2-2-2-0-1-1). the ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.

Eligibility criteria:
inclusion criteria: * age 18 - 60 years * who category iii rabies exposure * received rabies vaccination on day 0 and 3. exclusion criteria: * received rig * immunocompromised hosts or receiving immunosuppressive therapy * received blood or blood product within 3 months * received anti-malarial drugs

Keywords: rabies immunoglobulin